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Study was not funded
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Cardiovascular disease is the leading cause of mortality in kidney transplantation. The enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health and protects against cardiovascular complications.
This is a prospective, double-blind, placebo controlled, clinical trial examining vascular effects of allopurinol in patients who received a kidney transplant that are maintaining stable renal function for at least 1 year. End-points include pulse-wave velocity, systemic blood pressure and kidney function among others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol | Active Comparator |
| |
| Placebo (sugar pill) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allopurinol or placebo | Drug | Daily active drug (allopurinol administered orally) administered orally for 3 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Events | Number of major cardiovascular events | 3 years |
| Endothelial Function | Changes in flow-mediated dilatation of braquial artery. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness | Changes in pulse wave velocity. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto S Kalil, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52240 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allopurinol | allopurinol Daily active drug (allopurinol administered orally) |
| FG001 | Placebo (Sugar Pill) | Placebo: Daily placebo (sugar pill) administered orally for 3 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allopurinol | allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years. |
| BG001 | Placebo (Sugar Pill) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiovascular Events | Number of major cardiovascular events | No intervention occurred, so no data was collected for report. | Posted | 3 years |
|
Study did not start
Zero subjects considered 'at risk' for this study, as the intervention did not begin and zero subjects were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allopurinol | allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years. |
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Study did not receive funding so intervention did not begin.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roberto Kalil | University of Iowa | 319-355-6564 | roberto-kalil@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2017 | Sep 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Sugar pill administered orally for 3 years. |
|
allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Endothelial Function | Changes in flow-mediated dilatation of braquial artery. | No intervention occurred, so no data was collected for report. | Posted | 3 years |
|
|
| Secondary | Arterial Stiffness | Changes in pulse wave velocity. | No intervention occurred, so no data was collected for report. | Posted | 3 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo (Sugar Pill) | allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years. | 0 | 0 | 0 | 0 | 0 | 0 |
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